FDA initiative puts AR/VR at heart of home health drive
pharmaphorum
APRIL 24, 2024
A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system
Sat.Apr 20, 2024 - Fri.Apr 26, 2024
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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?
Fierce Pharma
APRIL 23, 2024
Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.
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Pfizer and BioNTech commence legal action against Moderna in UK court
Pharmaceutical Technology
APRIL 24, 2024
Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.
How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?
MedCity News
APRIL 25, 2024
Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry.
FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt
pharmaphorum
APRIL 23, 2024
After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’
Fierce Pharma
APRIL 26, 2024
After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.
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Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines
MedCity News
APRIL 25, 2024
Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics. The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News.
Owlstone secures $6.5M for breath-based diagnostics for infectious disease
pharmaphorum
APRIL 26, 2024
Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.
Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate
Fierce Pharma
APRIL 23, 2024
The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.
Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment
Pharmaceutical Technology
APRIL 22, 2024
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery
MedCity News
APRIL 23, 2024
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.
LogiPharma Europe 2024: LogiPharma Commercial Director Discusses Themes of the Show
Pharmaceutical Commerce
APRIL 23, 2024
In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.
Roche's Vabysmo shows no sign of slowdown after Regeneron and Bayer's launch of Eylea HD
Fierce Pharma
APRIL 24, 2024
It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. | How much impact has the approval of high-dose Eylea had on the upward trajectory of Roche’s Vabysmo? Not much, according to sales figures released by Roche.
EC approves Pfizer’s Emblaveo for multidrug-resistant infections
Pharmaceutical Technology
APRIL 23, 2024
The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.
How to Stay Competitive in the Evolving State of Martech
Advertiser: ZoomInfo
Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Providence Ordered to Pay $200M for ‘Systemic Wage Violations’
MedCity News
APRIL 24, 2024
More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.
Moderna banks on OpenAI to accelerate mRNA research
pharmaphorum
APRIL 26, 2024
In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.
AbbVie's Skyrizi proves a worthy Humira successor with nearly matching sales ahead of potential UC nod
Fierce Pharma
APRIL 26, 2024
AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.
Avidity Biosciences gets grant for polynucleic acid conjugate for treating FSHD through rna interference
Pharmaceutical Technology
APRIL 22, 2024
Discover how Avidity Biosciences' patented polynucleic acid molecule conjugate targets the DUX4 gene to combat FSHD. Learn more about this groundbreaking approach in gene therapy.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care
MedCity News
APRIL 26, 2024
Johns Hopkins Hospital teamed up with Healthy.io, a company that offers smartphone-based technology to improve wound care management for diabetic patients. The partners are conducting a 120-person study to measure the impact of the startup’s technology. The post Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care appeared first on MedCity News.
Novartis names ex-BMS CEO Caforio as chair amid strong Q1
pharmaphorum
APRIL 23, 2024
Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results
Eli Lilly inks deal to acquire Nexus manufacturing plant in WI as Mounjaro and Zepbound shortages drag on
Fierce Pharma
APRIL 23, 2024
As doctors and patients in the U.S. | As doctors and patients in the U.S. grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines.
BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant
Pharmaceutical Technology
APRIL 22, 2024
Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
BMI: A Flawed Measure of Health
MedCity News
APRIL 26, 2024
It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. The post BMI: A Flawed Measure of Health appeared first on MedCity News.
With $75m cash injection, SynOx plans ph3 rare tumour trial
pharmaphorum
APRIL 22, 2024
Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.
AstraZeneca CEO says platform deals largely done after M&As in vaccines, radioligand, cell therapy
Fierce Pharma
APRIL 25, 2024
After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin. | After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin.
Vistagen’s on-demand nasal spray could provide a novel option for social anxiety
PharmaVoice
APRIL 22, 2024
The fast-acting medication is one of a few new approaches being tested for the crippling condition.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
It’s Time to Give Patients a Seat at the Table
MedCity News
APRIL 24, 2024
Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. The post It’s Time to Give Patients a Seat at the Table appeared first on MedCity News.
Roche says it has shed 20% of NMEs from its pipeline
pharmaphorum
APRIL 24, 2024
Roche chief executive Thomas Schinecker said today that one in five of the pharma division’s pipeline of new molecular entities (NMEs) has been culled in the last few months as part of a shift in focus on “high impact” projects.
Day One takes on Novartis with FDA nod for Ojemda in broader common childhood brain tumor use
Fierce Pharma
APRIL 23, 2024
Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.
Eli Lilly Purchases Nexus Pharmaceutical Injectables Manufacturing Plant
Pharmaceutical Commerce
APRIL 25, 2024
The deal further grows the Big Pharma company’s US production capabilities, especially when it comes to global parenteral products.
ABM Evolution: How Top Marketers Are Using Account-Based Strategies
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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